U. S. Food and Drug Administration
U. S. Department of Agriculture
December 5, 1997
GUIDANCE ON GOOD AGRICULTURAL AND
MANUFACTURING PRACTICES FOR
FRUITS AND VEGETABLES
- - -
PUBLIC HEARING
HELD ON FRIDAY, DECEMBER 5, 1997 AT
THE CLAYTON HUTCHESON AGRICULTURAL CENTER
559 NORTH MILITARY TRAIL
WEST PALM BEACH, FLORIDA
- - -
2
PANEL MEMBERS:
Lynn Isaacs, Regional Public Affairs Specialist, FDA
Mike Chappell, Acting District Director, Fla. Dist., FDA
John Vanderveen, Ph.D., Acting Deputy Center Director,
CFSAN, FDA
Martha Roberts, Ph.D., Deputy Commissioner for Food and
Safety, Florida State Department of Agriculture and
Consumer Services
Clayton Hutcheson, Director, Palm Beach County
Cooperative Extension Service
Douglas L. Archer, Ph.D., Chair and Professor, Food
Science and Human Nutrition, University of Florida
Richard Barnes, Food Safety Initiative Staff, FDA
SPEAKERS: PAGE:
Mike Chappell 6
Dr. John Vanderveen 14
Dr. Martha Roberts 19
Clayton Hutcheson 28
Dr. Douglas Archer 29
Richard Barnes 37
Q & A Session 103
Dr. Ricardo Gomez 121
Dr. Stacey Zawel 136
Mike Stuart 138
Bobby McKown 149
Dr. Chip Hinton 158
Dr. Mohammed Ismail 169
Dan Riche 185
Wes Roan 195
Dr. Jean Malecki 203
Gary Smigle 216
Mary Dettmars 218
Al Yamada 224
Rebecca Schleifer 229
Stephen Paige 232
Dr. Stacey Zawel 238
Dr. Mohammed Ismail 240
Lauren Gould 241
- - -
3
(The following Public Hearing commenced at
9:10 a.m.)
MS. ISAACS: Good morning. Thank you for
joining us this morning, and we also thank our
head table of participants for weathering the
weather yesterday and joining us.
You all should have a copy of the agenda in
your packets, the new and improved agenda as of
this morning, and I'm going to go through here
and briefly introduce our participants here.
Down at the far end is Dr. John Vanderveen.
John is the Acting Deputy Center Director with
FDA Center for Food Safety and Applied Nutrition.
Next to John is my boss, Mike Chappell, the
Acting District Director of the FDA Florida
District Office.
And next to Mike is Dr. Martha Roberts.
Martha is the Deputy Commissioner for Food Safety
with the Florida Department of Agriculture and
Consumer Services.
And then we have former FDA'er, Dr. Douglas
Archer, who is a Chair and Professor, Food Safety
with the University of Florida, Food Science and
Human Nutrition.
Did I get that sort of right, Dr. Archer?
4
DR. ARCHER: Certainly.
MS. ISAACS: All right. Just checking.
John, who was going to introduce Terry, but
I guess I'm introducing Terry. Terry Troxell.
What is your title, Terry, with CFSAN?
MR. TROXELL: Director of Programs and
Enforcement Policy Commission and of Dairy, Food
and Beverages.
MS. ISAACS: And one of the drafters of the
document.
Okay. And we have my other boss, Richard
Barnes, is the Director of FDA's Division of
Federal State Relations in Rockville, Maryland.
And we have Clayton Hutcheson. Clayton is
the Director of Palm Beach County Cooperative
Extension Service, whom I'm sure a lot of you
know, and we certainly appreciate his hospitality
today and he's going to be giving some welcoming
remarks.
Okay. Let's give a little background
information about this initiative. On
October 2nd of this year, President Clinton
announced a plan entitled Initiative to Ensure
the Safety of Imported and Domestic Fruits and
Vegetables.
5
As part of this initiative, the President
directed the Secretary of Health and Human
Services, in conjunction with the Secretary of
Agriculture, and in close cooperation with the
agricultural community, to issue guidance on good
agricultural practices, affectionately referred
to as GAPS?
Do you call them GAPS, too?
MR. TROXELL: GAPS.
MS. ISAACS: GAPS. And good manufacturing
practices, GMPs for fruits and vegetables.
FDA and USDA have developed draft working
papers that addressed microbial food safety
hazards and good management practices associated
with water quality, sanitation, hygiene,
transportation, manure and municipal sludge
common to the growing and harvesting of most
fruits and vegetables that are sold to consumers
in an unprocessed or minimally processed form.
These preliminary drafts are intended to be
further developed and refined to assist growers
and handlers in examining their operations for
potential microbial hazards, and in identifying
management practice options that may be adopted
to minimize the risks of microbial contamination
6
for fresh produce.
So the purpose of this meeting is to solicit
your input on this draft guide. This meeting is
part of a series of town hall meetings that are
being held across the country. A public meeting
was held in Washington, D. C. on November 17th
and approximately 150 people attended. Comments
from that public meeting are included in the
draft of the guide that will be presented today.
I believe there is going to be another
meeting Monday to address international concerns;
that's also in the Washington, D. C. area.
Grassroots town hall meetings have also been
held this week in Grand Rapids, Michigan on
Monday, they had about a hundred folks there, and
Geneva, New York on Wednesday attracted about 75
attendees.
So today we hope to get your comments, your
reactions to this draft guide and, later on, if
you get home and think of additional points, you
can go ahead and submit a written comment to the
FDA.
Your information packet includes an
announcement for this meeting, and that
announcement tells you where to send additional
7
comments, and it's very important that you
include the docket number with that comment. So
we encourage you to do so after we go away today.
This meeting is being transcribed so that
the scientists preparing the guidance document
can carefully review your comments and make
revisions to the document as appropriate.
As far as housekeeping, some of you may have
found the rest rooms already right outside the
entrance. There will be coffee, we hope. It has
been ordered. There are several restaurants
close by, and Clayton has provided a map to the
ones closest to us. We really want to just break
for one hour for lunch and be back here to get
the input from you all.
We hope that you all picked up an
information packet about FDA and USDA at the
registration desk. And we intend that today's
meeting will be informal; you will have ample
opportunity for comment.
As you see from the agenda that we're
scheduled to adjourn at 4:00 o'clock, but I'm
sure if there's a lot of interest, that everybody
will stay till the last person is heard. Am I
right?
8
Okay. In addition, if some of you don't
really want to make your comments orally, we have
a little written two-part form, comments,
questions, and Frank Goodwin has those available
for you; just fill it out and raise your hand and
Frank will collect it and we'll get it to the
right panelist up here and address your concern,
and I'll read your comment or question.
Okay? Are there any questions thus far?
All right. Well, let's start off with Mike
Chappell.
MR. CHAPPELL: Good morning.
I think if we're going to hear from these
people, we're going to have to have a little more
enthusiasm.
MS. ISAACS: Try it again.
MR. CHAPPELL: Good morning. A little
better. You might want to tone them down toward
the end of the day.
Well, I'm here on behalf of the Food and
Drug Administration to welcome you to this town
meeting, as well as representing John Turner, who
is the regional director for the Southeast Region
of the Food and Drug Administration.
I'd like to emphasize a few points, very few
9
points about the President's Initiative and our
purpose here today. First of all, it is a
collaborative effort. It includes the United
States Department of Agriculture and state and
local Departments of Agriculture, and,
importantly, for today's meeting, it includes
you.
As Lynn mentioned, this is one of a series
of meetings -- I think this is the third of six,
I guess we held them last week, and there will be
some next week also -- throughout the country to
hear your concerns. The meeting that Lynn
mentioned on Monday in Washington, December the
8th, will deal with international concerns.
The use of the town meeting is -- or the
grassroots meeting is fairly new to FDA. We,
really, over the last few years as part of, I
guess, a re-invention of government, we began to
use these instruments more in getting people's
input earlier on in the process of developing
guidelines and regulations.
And it's certainly appropriate to do that,
because if you look at the history of this
country, that is a forum that has been used
throughout history to understand what the people
10
really need, the people really want, and the
people's concerns.
So this is a forum; this is your forum, this
is your opportunity to speak with us, to share
with us your concerns and certainly understand
what we're going to be giving you today and
presenting to you. Certainly, we ask that you be
frank, you be open with us, and we'll certainly
do the same with you.
I think it's very appropriate that we're
having one of these meetings in the Southeast,
particularly here in Florida. The Southern
United States and Southeastern United States
produces a significant portion of the fresh
fruits and vegetables consumed in the United
States.
And it's also in this area where we have a
wide variety of representatives of the producers.
We have everything from the small family farm to
the major agribusinesses. And this is, again,
your opportunity to talk about these issues, to
understand these issues and let us know how you
feel about them.
I'd like to mention a little bit about -- I
mentioned the Southeast Region. The Southeast
11
Region of the United States is composed of eight
states, the Commonwealth of Puerto Rico and the
U.S. Virgin Islands. There is a district --
district throughout the Southeast, they are
located in Atlanta, Orlando, San Juan, Nashville,
and New Orleans. There are about 500 of us. We
have two laboratories located, one in Atlanta and
one in San Juan. There's about 125 people
associated with those laboratories. The rest of
us in those district offices and the 28 other
support offices for those districts comprise the
500 people in the Southeast.
The laboratories analyze thousands of
products in the course of a year, generating
hundreds of different analyses to ensure that the
products that we regulate are safe, effective,
and wholesome.
The rest of us throughout the inter-lands
and in these other offices that I mentioned, are
basically the field investigational force; we do
the inspections, we conduct investigations in
support of the Food, Drug and Cosmetic Act and
other associated acts.
But FDA overall is involved in the
production, import, transport, storage, and
12
monitoring of products that account for about
$750 billion a year in our economy. So we have a
major job and, of course, food safety is one of
FDA's major concerns.
It is our responsibility to make sure that
the food on American's tables is both safe and
wholesome. And part of that process is to try to
prevent problems before they occur. And as part
of that, one of the things we do is try to assess
risks associated with these products, and that is
one of the bases for our public health
commission.
Based on our public health responsibilities,
the President has charged FDA to take the lead in
developing a guidance document to assist farmers
in minimizing microbial hazards. I must
emphasize that we are developing guidance and not
regulations.
Those of us within FDA understand the
difference and we understand the possible
nuances. And I know for people who are not that
familiar with it, it may get muddled and one may
appear to be the other.
And I think as we go through the day -- and
I ask you to pay particular attention to this --
13
we're going to talk about the differences between
guidance and regulations and how that really will
affect what this whole process is about.
The President's Initiative does not require
new regulations on microbial safety of foods.
You'll hear that repeatedly throughout the course
of the day and it's important for you to
understand that.
Richard Barnes, who is now part of the food
safety initiative -- I guess in his former life
he's a director of the Division of Federal State
Relations, and many of you may already know him,
but he'll talk a lot more about this -- the
regulation, per say, and the differences in the
guidance.
The task at hand is twofold for us: First,
we're going to review some of the major features
of President Clinton's initiative on fresh
produce, and Richard will give you some of the
background on that and the forces that led to it.
Secondly, and most importantly, we need to
have your input on the draft guidance on good
agricultural practices, which Lynn has already
referred to as GAPS.
The drafts in your information packet, it's
14
fairly fresh, I think we got it just a few days
ago, and it represents our first stab at this.
It does represent input from the both the
sciences at USDA and FDA, and they represent only
preliminary thinking on our part.
Obviously, you have to have something to
start with, something to get the discussion
going, and that's what this is.
The produce subcommittee of the National
Advisory Committee on Microbial Criteria and
Foods, which is an advisory body to FDA, has
reviewed this draft, and it's my understanding
their comments have been incorporated.
So now it's your turn. We expect you to go
over this with us, give us your comments, ask
questions. It's really important that we
understand each other. If you don't understand
something we're saying, you need to be clear on
that. And, likewise, we need to be clear on your
thoughts and feelings.
All of these town hall meetings, all of
these grassroots meetings, the comments will be
carefully analyzed, they will be reviewed prior
to issuance of the final draft document, which
will be issued in the Federal Register early in
15
1998.
Even after it's been issued, there will
certainly be a comment period, and you'll have
another opportunity to comment on that draft at
that point. It also will be -- it is now posted,
as I'm sure the -- when the final draft goes out,
will be posted on FDA's web site or Internet
site.
If you picked up one of these blue folders
outside, you already have the FDA Internet
address. It's on -- it's certainly on this
particular insert. If you haven't picked that
up, please do so. We've become so accustomed now
to using the Internet to provide information
that, in the field, this is the first place we go
to find out what's the most current thinking in
the various centers within FDA.
So I encourage you to use that to certainly
see what's happening, what's going on, not only
in this initiative, but in other areas of FDA.
Well, we got a little bit of a late start,
but I certainly want to make sure I don't step on
anybody's toes, talk about things that's going to
be addressed further, so I'm going to stop now.
But I do want to encourage you to be open,
16
to be frank with us. We're here to listen, and
I'm sure that if -- there's going to be plenty of
time for questions and just so we can hear your
concerns and comments.
So with that, Lynn, I'll turn it back over
to you.
MS. ISAACS: Thank you, Mike. And the FDA
home page is www.fda.gov. And you will find a
wealth of information on it.
Okay. Dr. Vanderveen, you're next.
MR. VANDERVEEN: Thank you, Lynn.
I'm John Vanderveen, as Lynn has told you,
and I would like to extend my welcome to all the
welcomes that you'll get this morning on behalf
of the Center for Food Safety and Applied
Nutrition and all of our partners in this food
safety initiative.
And there are six partners; there's several
sections of USDA that are actively involved with
this. The Center for Disease Control, the
Environmental Protection Agency is playing a
significant role, and we are all very pleased
that you have taken the effort to come here
today. We recognize that you have busy
schedules, we recognize also that some of you
17
have come long distances, and we're very pleased
that you're willing to make that effort.
I'd like to introduce one other person. I
think Camille Brewer is back there in the back of
the room. Camille is one of our compliance
officers, and she's been the project manager for
a number of these efforts, produce initiative
efforts, and she has been largely responsible for
organizing much of what you're going to see
today.
I would like to mention the fact right off
that we have the safest food supply in the world.
There is -- we continue to say that, we're very
proud of that. USDA regulating meat and poultry
and FDA regulating a good portion of the other
food supply. We are very, very pleased all the
time with the response that the farmers, the
processors, and retailers do in making our food
supply as safe as it is.
Nevertheless, there are problems from time
to time and we have to expect that, I guess, but
we always try to make things better.
As you heard, the President, two months ago,
initiated this produce initiative and we are very
anxious to fulfill the goals that he's outlined
18
in this. But our main purpose is to gain from
you your advice, your counsel, your constructive
criticism and gain from the benefit of your
knowledge. I'm the first to admit that we can't
be in your shoes at all times and know all the
nuances that are important in trying to do what
we're trying to do in this area.
I want to acknowledge, also, that there has
been significant input to where we are at the
present time from the industry. The trade
associations, the educational arms of those trade
associations have played a significant role in
recent years in trying to guide us in what needs
to be done relative to such a guide as we're
trying to put forth today.
I've met with a number of trade associations
over the last two or three years; they have sent
me their materials and asked for my input to it,
and we're very pleased that they're working so
hard in this area, and we hope that this
relationship can continue in a very positive
manner.
There's more about this initiative on
produce that I want to emphasize and just take a
moment to do it. As you've already heard, this
19
is a guidance document that we're trying to
prepare and we think it's very important for
various reasons.
It's about partnerships between government
agencies, farmers, transportation processors,
retailers, and even the consumer, and it's about
a new paradigm where the government will place
more emphasis on helping to prevent food safety
problems by establishing good agricultural
practices and good manufacturing practices and
less on traditional end item inspection and
testing.
We just don't have the resources; it's just
not a good way to operate, and as a consequence,
we want to enter into a much more -- we hope that
with Seafood HACCP you will see the results of
this partnership starting in January, and we will
soon have an in-juice HACCP proposal in the
Federal Register.
And we hope that you will understand that
this is a program where we're trying to work with
the industry and try to prevent problems and not
rely on the traditional compliance approach to
gaining food safety.
We want to establish also a dialogue, and we
20
want you to be able to feel free to come in to
see us from time to time if you have problems.
We've always had our doors open to talk with
people and we want to emphasize that as well.
I think that there's one other aspect I
would like to talk about today, and that is the
fact that, in developing this guide, is for -- as
you'll hear today -- for our domestic industry,
but the guide is very important in dealing with
our trading partners as well.
As you know, there are various trade
agreements required, that we have standards that
are equal between those for domestic and those
for imports of all our products. And we must
start out by defining what our standards are, and
then only in that way can we say to foreign
governments, this is our standard and we expect
you to meet that standard.
So I emphasize that, although we're working
on a guide for domestic production of foods,
we're anxious to use that guide eventually as our
standard as what we expect from other imports to
this country.
In closing, I'd like to say just two things:
I appreciate very much Mr. Hutcheson's efforts to
21
have us here in this very nice facility. I'm
with the 4-H -- I guess I was going to say
student -- but 4-H member for about 12 years 45
years ago, and I must say, things weren't quite
this good. We usually met in the middle of a
dairy farm barn floor or someplace like that, not
nearly as nice as this, and we certainly
appreciate your kind invitation here, and we hope
all of you will participate very fully today.
Thank you very much.
DR. ROBERTS: I bring you greetings from
State Government, Commissioner Bob Crawford,
Commissioner of Agriculture for the State of
Florida welcomes you, and we're delighted to be a
participant in this meeting and to gain
perspective from everyone involved.
We commend FDA and commend USDA for trying
to address this issue and for allowing
participation by state government, by industry,
by consumers, and all stakeholders.
Quite frankly, it's unbelievable that we
have a major political initiative that is very
scientific issue of food safety, and I think,
quite frankly, it puts us into a different arena
and casts some different perspectives that we're
22
all having to deal with as we go forward on this
very major initiative.
So as state government, we're prepared to
work very closely with our federal partners, FDA
and USDA, to ensure that we have a very science-
based common sense guidance to the industry.
We're very pleased that FDA has been charged to
develop this in cooperation in partnership with
USDA and to set standards for imported and
domestic product.
Food safety is a major priority of the
Florida Department of Agriculture and Consumer
Services. It is the department's priority, it is
the public's priority, industry's priority,
universities and health professionals alike.
Within the department, we focus on the
potential microbial risk, attempting to prevent
it through good sanitation and hygiene and to
provide the safest food supply to our citizens in
our inspection and laboratory testing programs of
the State.
We're emphasizing examination for food-borne
pathogens, everything from Salmonella to E. coli
to Listeria, and would like analytical procedures
for other things, such as cyclospora that we have
23
to deal with as food-borne risk in the State of
Florida.
The State of Florida is responsible for the
inspection and laboratory surveillance of over
28,000 retail food stores, warehouses, and
processing establishments in the State of
Florida. We have almost 300 individuals
associated with this program, and we're delighted
that one of these public meetings is held in the
State of Florida. We think it's a very
appropriate location.
For many years, this very county in which
we're seated was the fourth and fifth largest
agricultural county in the United States
producing over $1 billion in cash receipts in a
whole host of fruits and vegetables. But yet,
due to the impact of many government regulations,
state, federal, local, as well as increasing
competition from imports, within the last census,
we have seen this county dwindle from fourth or
fifth down to 11th.
We feel that this is an apt place to have
this hearing because of the diversities of
agriculture in this county. And it is also very
appropriate because this was one of the very
24
first counties in the nation over three years ago
where we started experiencing so many cases of
food-borne illness from a unbefore recognized
parasite, cyclospora. I'm very glad that
Dr. Jean Malecki will be later talking a little
bit about that, as far as the numbers of cases
experienced here in this county from imported
strawberries.
And this county is also the site of some
very proactive citizen groups. We have some
senior citizen groups in the area that are
extremely active with the department, are trying
to do more in the whole area of helping the
department to enforce our country of origin
labeling laws so that the general public will
know the source of fruits and vegetables that
they are eating.
So we are a state in which we have a
tremendous partnership. Our philosophy in the
State of Florida has always been cooperative.
We've had innovative partnerships with federal
government, with state government, with local
government, with our industry groups, with
consumer groups, with our universities, and with
Extension Service, and we feel that that's the
25
very best way to attack problems.
We're a state where every one of these
groups has, as their major focus, food safety
consumer issues and water and environment, and
they're all priorities for state government
federal consumer groups, industry and
universities alike.
So this partnership is excellent and we
focus on partnerships as the necessary step in
this guidance. But we'd also like to look at the
goal of health. And within my welcome, I'd like
to make a few comments relative to that, because
that is the ultimate goal of any GAPS or GMPs
relative to this industry, is to increase the
public health in this country.
And I am personally concerned that, as we
have any further drop in domestic production of
fruits and vegetables with any increased
importation from third world nations, that we
make certain that we apply the current
regulations on sanitation and production to the
importation from other nations.
It is very difficult for us to absorb
reports of all sewage and irrigation waters on
nations from which we're having product imported.
26
If we reduce domestic production, have we
increased public health safety in this country,
and I do not think that we will have.
One of the major parts that we strongly
support in the document is the area concerning
water concerns and water impact on food safety.
We are a state that has very major complex
regulations involving water safety, water
quality, and the source of water.
Water in the State of Florida is regulated
very strictly by our five water management
districts as far as the Florida Department of
Environmental Protection. The actual water
allowed to be used by agriculture is given to
them on a water use permit that allocates to
agricultural uses specific quantities of water
annually and the specific source of that water.
So they could not, and it would be very difficult
to immediately change any source.
But the water use in agriculture is about
60 percent farm ground waters with about
80 percent of many of our industries already
having shifted to low volume drip irrigation.
Water we use is emphasized as a goal of the state
as far as use of reclaimed water, but edible
27
crops that will not be peeled, skinned, cooked,
or semi-processed before consumption are not
permitted to be using treated effluent.
We support any reasonable proposal that will
increase food safety in this nation. The number
of deaths and illnesses is unacceptable, but we
want to support something that will be based on
sound science, on advisory groups'
recommendations. We're very pleased that those
have been entered into the proposed draft.
We would hope that our federal counterparts
will support the additional research GAPS that
have been identified and that will base all these
good agricultural practice recommendations on
common sense and reality and risk to the public.
And we earnestly ask that what we have
currently in place as far as sanitary
requirements in the United States be initially
enforced on both domestic and imported product.
We need also to ensure that we're listening
to our voices, and that's why I want to commend
FDA and USDA for doing just that.
Today I'll be listening as a regulator.
I'll be listening with a regulator hat who's top
priority is food safety and who wants to ensure
28
the highest degree of safety to the foods that
we're purchasing, the foods we're producing, the
foods we're consuming.
We've got about 14.7 million citizens in
this state and over 40 million annual visitors.
That's a lot of meals being served and it's a lot
of food safety requirements.
I'll be listening as a professional
microbiologist who's very concerned with the
threat of the condition of some of the imported
products that we're seeing from nations not
having adequate sanitation.
If I'm told not to eat salads or fruits and
vegetables in a nation I'm visiting, even in the
very best of restaurants, why would I want to buy
them and purchase them once they're imported into
the United States. That's a personal philosophy.
As a microbiologist, I also know that dirt
and fields are not sterile and they can't be. I
strongly support, though, the requirement that
you can't expose the food to untreated human or
animal waste.
I'm listening as a member of an agricultural
agency that knows the efforts of our agricultural
industry to try to address food safety concerns
29
and prevent contamination. And I'm also going to
be listening to you as a mother and a grandmother
because I want the safest and cheapest food
supply. I want it to continue; I want the older
and the younger members of my family not to be
submitted to any undue risk, but I also want them
to eat more fruits and vegetables because it's
the best way, and one that our National Academy
of Sciences has recognized as the best way to
prevent cancer and chronic human disease.
So I commend FDA for their activity and I
commend them on having the National Advisory
Committee on Microbiology for Criteria for Foods
to address this issue. We would ask you to
thoughtfully consider the committee's
recommendation and to pursue those with all care
and deliberation.
We want you to continue, as you're doing
here, to actively seek the input of all parties
and we're delighted at that. And we thank you
for letting the input of those who know how
fruits and vegetables are grown in real life to
provide information to you.
We want to all work together to seek the
highest level of safety for the U.S. food supply
30
and to aggressively apply current standards. We
want you to actively support country of origin
labeling, too, so that consumers can know where
the produce that they're eating has come from.
We look forward to hearing from the
industry, we look forward to continuing to work
with FDA because we're a state in which
partnerships are effective and we want to see the
President's Initiative soundly and reasonably
applied.
Thank you.
MR. HUTCHESON: I wanted to take just a
moment to welcome you on behalf of Dr. Chris
Waddill, dean and director of the Cooperative
Extension Service here in Florida, she couldn't
be here today. But the Extension Service here in
Florida has a commitment to carrying out the
educational role that has been given to us over
the years.
As I look at what's going on here today and
what may come out of it in the future, we have
dealt with and provided educational services for
training of pesticide applicators leading to
their certification when that came along, that's
happening, of course, throughout the United
31
States, and Extension Services came through on
that. The worker protection standards, when that
came along, the Extension Service geared up to
make sure that educational programs were there to
be delivered to the agricultural people.
So Dr. Waddill has renewed her commitment to
make sure that the Extension Service here in
Florida is able to deliver and to provide those
educational services that are going to make a
difference for the industry here in Florida.
Whatever comes out of this meeting today and
ultimately out of this process, the Extension
Service will probably be -- have a responsibility
for doing some part of the educational role that
will be certainly associated with this.
Since my role is to remain unbiased and not
make any inflammatory comments, I'm going to kind
of stop there and welcome you to the facility.
I might say, there are some members of the
press here today. We have some tables over along
the wall; if that's more convenient for you, feel
free to use those.
But, again, on behalf of Dr. Waddill and the
Extension Service here in Florida, welcome, and
we stand ready to support the industry and to
32
make life as easy as possible at the end of this
entire process.
Thank you.
DR. ARCHER: I'm Doug Archer. I'm from the
University of Florida which is the land grant
school here in the State. And I don't speak for
the University of Florida; if you know much about
academics, nobody can represent academics, they
all have their own opinions.
In any event, I'm allowed to make
inflammatory remarks, unlike Clayton, so I'll
make a couple.
We're here today to talk about this
document, this draft guide. And when I was with
FDA, the last ten years I was with the agency, I
spent in Washington, D.C., and there used to be a
rule of thumb in Washington that when you put
something out, it had to pass the hee-haw test,
and if you think about that, it becomes self-
explanatory.
And I have to admit, when I was reading
this, I did get a few hees and haws out of it. A
couple of them I'll just mention that I think the
agencies might want to reconsider are some
provisions such as covering reservoirs. I spent
33
$15,000 to cover my swimming pool and I still
have frogs, snakes and other things that crawl in
and out of it, so I don't think that's a
practical solution.
Another thing that I think they might want
to reconsider is the control of migratory birds.
I'm not aware that migratory birds have to land
in order to defecate and, frankly, I'd rather
have them on the ground where they probably
aren't going to saddle up to the green bean bush
to do their business, rather than indiscriminate
bombing overhead. So I don't think it's possible
to enforce no-fly zones over the entire southern
half of the State of Florida.
Now that might sound funny, but I don't
think it's funny for a variety of reasons. I
don't think it's funny if, in any way, these
efforts, through publicity or whatever, decrease
the consumption of fresh fruits and vegetables
from whatever source.
Remember -- and Dr. Roberts brought it up,
but it's very important that we keep in mind --
the consumption of fresh fruits and vegetables is
the single most important preventive public
health measure in the United States. It saves
34
more lives than food-borne disease takes ten
times over each year. And that is a fact, it's a
medically proven fact; it's not speculation.
Now, why is this effort happening at all?
Well, I think Dr. Roberts also alluded to that.
There is a good dollop of politics involved as
well as some reality. There have been some
outbreaks associated with fresh fruits and
vegetables.
But where I take exception with some of the
information in the guide are the examples that
have been chosen. I mean, there are some real
outbreaks that can be cited. But why confuse
processed foods with fresh produce? Why bring up
frozen coconut milk? I'm not aware that that's
fresh produce. Why give false examples of
outbreaks?
And I just pulled one because it happened
here in Florida, and it's in the guidance
document and it cites the outbreak in 1995
involving fresh-squeezed orange juice at a theme
park here in Florida. And the add-on to that is
that, although the cause of the contamination was
not identified, at least one of the groups
supplying oranges to the implicated processor
35
irrigated with surface water that may have been
contaminated.
Well, if that's not speculation on
speculation, I don't know what is. Because the
cause of that outbreak, I think, was pretty well
established, and it had nothing to do with
irrigation water. So why have things like this
in a document that's going to have any credence
on the outside.
I think what you'll hear today from a lot of
people is, this thing is going too fast. Now,
there's a reason for that. FDA is in the
executive branch of government, and the Chief
Executive of the United States told him to do it
in 90 days. And when he speaks, you do it in 9O
days.
I did the same thing, I had to do the same
thing when I was there. I never have experienced
anything quite like this in the 20 years I was
with the agency, but nevertheless, that's why
it's on a fast track.
I wish the process would slow down and I
wish that more time and more care could be given
to putting things down on paper; because once
they're down on paper, sometimes they're very
36
hard to erase.
Well, I've said some negative things, but
what are the positives? I think there are some
good things here and good things that need to be
considered. I think anything that decreases
illness in the United States is a positive thing,
and if this effort can do that, more power to it;
let's get down to work and find the things that
will have the most bang for the buck and do those
things.
But where should the effort be? I mean,
there's a lot in here on all kinds of things in
the growing field, and is that really where we
ought to be focusing our efforts. And I say no.
At least in my opinion, no.
What I don't see in here -- I see some
illusions to it coming in the future, but I
really believe that the biggest bang for the buck
would be anything that could empower the consumer
and the end product user of fresh produce.
Educate them, give them the knowledge they need
to treat the food safely, not to contaminate the
food and subsequently cause people to become ill,
which many of these outbreaks have really
involved, taking Neem juice, putting it on
37
lettuce, feeding it to people and wondering why
they become ill.
I think the other big bang for the buck
would be for the agencies that regulate either
disinfecting compounds or sanitizing compounds to
be able to put those, and assure producers that
those compounds could be put on a fast-track for
approval. Without that, we have chlorine and we
have precious little else that's been really
approved and blessed by the federal government in
the way of food additives.
I think those are two things that the
agencies could do and where they could devote a
lot of these resources to really, really make an
impact.
Thank you.
MS. ISAACS: Thank you, Dr. Archer.
And we do do a lot in the area of consumer
education already. We have a network of consumer
affairs officers, now called public affair
specialists, about 40 of us total nationwide, and
we do work very closely with Extension.
In fact, one of the programs that the
Florida District office started with Brevard
County Extension Service several years ago was
38
recently recognized with -- they received the
Vice President Gore's Hammer Award for Excellence
in Consumer Education. So I just had to add
that.
Our main focus this year is food safety for
seniors and it's an elder education project, and
most of the volunteers involved with this are
family community educators affiliated with
Extension. And this particular program has also
been extended to several other counties in
Florida. And in your package, you will also see
a variety of some FDA consumer education
materials.
Okay. Are there any questions at this
point?
You can see how we're going to proceed;
Mr. Barnes is going to present an overview of the
President's Initiative and get into the GAPS,
take a short break, hopefully, the coffee will
have arrived, and then he will continue with his
preview and any questions that you have that need
to be clarified, break for lunch, a short
presentation by USDA, additional questions, and
open it up to industry group presentations, a
number of which have been -- to start us off,
39
have been arranged by United Fruit & Vegetable
Association, Stacey Zawel.
Did I get that right, Stacey?
DR. ZAWEL: Pretty good, yeah.
MS. ISAACS: Okay. We thank you all for
your participation.
Then we will open it up to comments from any
other stakeholders.
Now, we have seven folks lined up from the
Fruit & Vegetable Association members who are
going to kick off the industry presentations.
And anyone else who knows now that they're going
to want to comment, can sign up over there at the
desk. We have an industry sign-up sheet, and
also all stakeholders' sign-up sheet just so that
we'll flow a little quicker.
Okay? Any questions? Stacey?
DR. ZAWEL: Should I go to the mike?
MS. ISAACS: Whatever.
DR. ZAWEL: Martha, I had a question. Stacey
Zawel with United Fresh Fruit & Vegetable
Association.
Martha, you had stated in your introduction
something about imported strawberry outbreak.
DR. ROBERTS: I meant imported raspberry
40
outbreak.
DR. ZAWEL: Okay. Thank you. I just wanted
to clarify.
MS. ISAACS: Okay. Anybody else?
DR. ROBERTS: Thank you for the correction.
MS. ISAACS: Okay. Mr. Barnes? Come on
down.
MR. BARNES: Good morning. My name, again,
is Richard Barnes, and I am one of the team
leaders for the Food Safety Initiative Team
working at FDA.
I've been with FDA a couple of years as the
Director of Federal State Relations. I came to
FDA from the State of Oklahoma, where I was
Director of Consumer Protection before going up
and deciding to work with the Food and Drug
Administration.
A couple things I'd like before I get into
the presentation to talk about how we got to this
point, the President's Initiative, and then
actually talk about the good agricultural
practices.
First of all, several people have said, you
know, this is a -- why pick on the fruits and
vegetables. And we really are not. This is part
41
of a total initiative, and I don't know if you've
seen this report to the President May of 1997.
Food safety from Farm to Table, a National Food
Safety Initiative.
And I'm involved, complete with all of the
food safety initiative involving all of this, as
well as the produce and import food safety
initiative part that is leading to the guide to
minimize microbial problems, hazards in fruits
and vegetables.
The process, the President's entire program
is exactly that; it's from farm to table. It
takes the whole system and puts it together into
a package. And so it talks about what -- this
part of it that we're talking about this morning
and what happens on the farm and the producers,
packers and so on that lead up to the retail
distribution chain, through the retail chain, and
all the way to the consumers.
Several weeks ago, the secretaries of USDA
and Health and Human Services announced the
campaign called Fight BAC, B-A-C, which is a
consumer campaign with four things they're
concerned about in educating the consumer on
handling foods.
42
The 1997 FDA Food Code has been produced and
is out for distribution, and part of the food
safety initiatives is to encourage jurisdictions,
agencies to adopt the Food Code, which contains
the best science available for the retail
industry. Upgrading and looking at more good
manufacturing practices; the use of HACCP, Hazard
Analysis and Critical Control Points throughout
the processing and manufacturing industry for
food products, and also in now looking at retail,
and where that fits and how that all goes
together.
So this Food Safety Initiative is a
composite of everything from farm to table. It
puts us all together, all of us, as food safety
people protecting each other to ensure the safety
of our food supply throughout the entire thing.
So that's one part that I want to bring up.
Secondly, I'm going to walk over here and
turn the overhead on, and I'll keep trying to
talk, hopefully, you can hear me, the group isn't
real large, so that you can hear me.
People have asked about the schedule. This
is the tentative schedule that, as Dr. Archer
said, we are held to by the President of the
43
United States in trying to meet the guides that
he wants for the Food Safety Initiative and the
Produce Food Safety Initiative.
In November, on the 12th or 17th, there was
a public meeting that was held in Washington, it
was also held with the Produce Subcommittee of
the National Advisory Committee for the
Microbiological Criteria for Foods. I have to
stop and think when I say that.
As a result of that, the working draft of
the guide was produced and put out, which all of
you have. And I would like to ask you, how many
of you have seen a copy of the guide prior to
today? How many of you have had a chance to
really look at it? Okay. Good.
In my presentation a little bit later -- I'm
not going to go through word for word of the
guide -- we want you to be able to take time to
look at it; those of you who haven't had a
chance, those of you who have to digest it, to
look at it, and to provide comments not only here
at the meeting, but also the written comments
that you're able to do through the end of
December. In January, we're going to compile and
evaluate all of these things that are being done.
44
Again, as we told you this morning or at the
beginning, there's a transcript being provided.
Those transcripts are going to be gone through by
the scientists at the agency. We're also looking
at bringing in our other people to assist us
during this entire process of the whole food
safety initiative; state people, industry people
that are going to assist in this whole process.
Then, from that, we're going to publish a
notice in the Federal Register sometime in March,
where there will be another comment period. At
the end of the comment period, there may be
another meeting, depending on what's necessary,
what comes out of all the comments. And then,
sometime in July or later, the availability of
the final guide will be produced.
Now, is this hard and fast, somebody said.
And as of yesterday, my meeting very early
yesterday morning, no, it is not. We are held to
what the President tells us, but some of it may
be shifted back a little bit, and that is based
on the comments that we're getting from people
from the first two grassroots meetings. So some
of this time line may be moved back somewhat as
we go through the process.
45
Okay. Any questions on that I'll take?
That's just a very brief overview of the
schedule.
Now I'm going to have to turn -- we're going
to use some slides, so I'll turn the lights down
a little bit when I get ready to do that, and if
I don't get lost in my notes, we'll be all set in
being able to read my notes from up here.
We encourage you to ask questions. One of
the reasons I came to the Food and Drug
Administration -- Dr. Vanderveen talked about the
change in paradigms -- and one of the reasons
that I applied and was very excited about going
to work for Food and Drug was the fact that I was
going to be a part of the change of the paradigms
at the agency.
I'm here and I like to be here and I'm glad
to present here because it involves my view and
my change of paradigm, my guess for this, and
that is that it involves everybody. It involves
the state, it involves the growers, it involves
the producers, it involves the consumers to have
input into things, which is a change from the way
things have been done in the past.
And so that's why I'm part of the team, is
46
to encourage and to make sure that I remind
everybody during the whole process that we want
the input from as many people as possible to make
sure that this is a consensus document; that this
guidance -- and I'm going to stress that word
over and over again -- that this guidance has the
input of everybody who wants to have something to
say into it before it's finalized.
Okay. If you could turn the slide projector
on for me please, Camille? See how we have to
adjust the lights.
Can you see that? Good.
Initiative to ensure the safety of imported
and domestic fruits and vegetables. In October
of 1997, the President announced a directive to
improve the safety of fruits and vegetables for
both domestic and those imported from foreign
countries. In his message, he wanted to develop
guidance to the industry that would not have the
force of regulation, that would not be a
regulation, but would provide guidance to the
industry, taking the input of everybody who was
interested to help improve the safety of fresh
fruits and vegetables to minimize the risk from
unsafe produce.
47
Again, several people already have talked
about the outbreaks that have occurred over the
past years, and there have been several of those
that have occurred from both domestic and from
imported produce, but the goal is that we want to
have the safest produce available to our
consumers.
And we do have that, and the President said
so in his message, that we do have a very safe
produce supply, but that we wanted to increase
it. And we want to increase it because both he,
the National Cancer Institute, the Food and Drug
Administration, the USDA, all support the idea
that more fruits and vegetables, fresh fruits and
vegetables are important to the health of our
nation and our citizens and our consumers.
We all know that the idea of having fresh
fruits and vegetables in our diet is important to
our national health and that we want to keep it
that way, we want to keep it safe and we want to
make it safer as we go through this entire
process of the farm to table food safety
initiative, improving the safety of foods all the
way along the line.
The elements of the initiative include a
48
legislative element, that one's already been
done. On November 23rd, a bill was introduced
into Congress to give the Food and Drug
Administration the authority to work on imported
foods very similar to what USDA, FSIS has for
meat and poultry products. It would allow us
to -- and I have some of the dates -- it was
supported by -- introduced in the House of
Representatives on November 13th, it's HR-3052,
it's called The Safety of Imported Food Act of
1997.
And essentially what it says is it changes
21-CFR, or the -- I'm sorry, not 21-CFR, but the
Food, Drug and Cosmetic Act, to add some language
that would allow the Food and Drug Administration
to look at foods that come into the country based
upon -- and I'll say that have not been imported
in the United States, that have not been
prepared, packed, and held under a system of
conditions or subject to measures that meet the
requirement of the Act, or otherwise achieve a
level of protection required as determined by the
secretary.
Well, there are several steps that the
agency must go through before that's done, and
49
there are several things that are different from
what the USDA has. There would be no
pre-approval, for example, what FSIS has is going
into foreign meat plants. We have to show as an
agency how we would enforce such a rule, how we
would implement it. We'd have to show that no
one would be denied entries of products into the
country or that there would be licensing or pre-
approval, for example, like low-acid canned
foods. So all of that has to take place as a
result of this legislative proposal before any of
it happens.
The administration portion of it is the
guidance to industry, which we're going to talk
about shortly, the good agricultural practices,
and eventually good manufacturing practices, as
well, to deal with that segment of the industry
from the farm up through other places where it is
controlled already under the CFRs.
And I hope that all of you understand when I
say CFRs, what I'm referring to it's the Code of
federal regulations; it's the documents that
guide the Federal Agencies and have the rules and
regulations written into them. 21 Series is the
Food and Drug Administration, for example, the 40
50
series is the Environmental Protection Agency,
and so on.
You're going to hear me talk a lot this
morning about good manufacturing practices that
are already in place for producers and
manufacturers. The good manufacturing practice
is Section 110 of the 21 CFR series.
And then there's also a budget request, and
that would be for '99, for FY99. There is no
money budgeted for this initiative in FY98. So
some of the things that would be done under it in
both domestically and imported for it would be in
FY99.
And the biggest requirement why we're here
today is that we had a requirement to report to
the President within 90 days of the October thing
on where we were and how we were going, how this
process was coming together, how the project was
working, good agricultural practices, good
manufacturing practices, what the schedule would
be for all of those things to get it done.
And as Dr. Archer said, the man that we work
for made the request that we do that in 90 days,
and we're trying to adhere to it as much as we
can.
51
Under the administrative section, the FDA,
in conglomeration with the USDA, is to issue,
within one year, the guidance for good
agricultural practices and guidance for good
manufacturing practices.
As a part of that, beside those guidance
documents, also, then, we're going to work
together to coordinate assistance and educational
activities to both domestic and the foreign
industry, the farming and producing industries,
and both of them will be done as a part of that.
Already, there has been cooperation between --
Cooperative Extension Service talks about doing
some of this, as well as hooking on to what's
being done, as I talked about earlier, on the
other Food Safety Initiative as well.
There it is again; guidance, not regulation.
Several people -- and we have said that you're
going to hear that too much, and perhaps I need
to just reinforce it again. That is the goal of
this document. We want it to be a guidance
document, an assessment, a self-assessment, to
use another word, for the growing community to
look at their practices, to help improve their
practices, to help increase the food safety or
52
the safety of food, fruits, and vegetables in the
in the food safety chain.
It's to help the farms, the growers, and the
producers identify the appropriate practices
where you can minimize microbial hazards. And
the cartoon underneath that is Fight BAC; that's
the one I talked about that's being geared
towards consumers in the country. There was a --
the secretary's released last month, you're going
to see more of him in many things.
And there's four areas, again, in that to go
along like the four areas of the good
agricultural practices; clean hands, avoid cross-
contamination, proper temperatures, and cooking.
Good Agricultural Practices, the Guide to
Minimizing Microbial Food Safety Risks for Fruits
and Vegetables is the document that we're going
to look at a little bit later. That's what they
want -- or the President wanted us to produce, to
do. It is a broad scope document. It is going
to be very broad.
Many of the things you've already heard this
morning, Dr. Roberts talking about the water in
Florida, for example, there will be sections of
the guidance document that are not going to
53
apply.
In other discussions we've had, for example,
the amount of manure that's used in vegetables
and fruit production in the State of Florida, for
example, is very minimal, except for chicken
litter, perhaps, in some areas. So it's going to
be different areas of the country that are going
to have different parts of that document be
important to them, depending upon local laws and
regulations, depending upon current practices.
And that's why we're here. Again, we're
here to let you tell us what things will work for
you, what won't, and if things are left out of
the document that we have not considered, that
those things get -- become a part of it as well.
We've already talked about the public
meeting that happened in November and these
meetings. The international meeting will occur
next Monday in Washington, D. C., and there also
is a second explanation of the good agricultural
practices meeting that's going to occur, I
believe, in Miami sometime next week.
Now this -- I left this slide in because it
was used at the other grassroots meetings.
However, I can tell you that the specific GAPS,
54
good agricultural practices, good manufacturing
practices for four fruits and vegetables is being
reconsidered. And as a result of the comments of
the grassroots meeting, although we never had any
criteria had been decided of what would be used
for these fresh fruits or vegetables, none had
been selected; it was intended that it will all
come through a public notice, a Federal Register
notice and public meetings.
At this point in time, as a result of the
first two grassroots meetings and input from the
industry, this is being reconsidered on whether
or not there will be some specific -- this year
or anytime in the near future -- whether there
will be specific good agricultural practices or
good manufacturing practices for four fresh
fruits and vegetables during FY98.
So I've left this slide up because it was
part of the other grassroots meetings, but also
tell that you this whole process for the specific
GAPS and GMPs is being reconsidered.
Outreach and educational activities are a
big part of this process. Assistance to the U.S.
farmer by the FDA and USDA on implementing the
good agricultural practices, the new FDA
55
Extension Service, educational programs,
assistance with people that you are used to
working with and being part of your farming
community to assist you in doing an assessment of
your growing practices.
There's also going to be, in FY98, technical
assistance to foreign countries. To initiate the
development of training modules and to coordinate
the development of non-FDA training network,
which might involve industry groups, which might
involve associations, which might involve private
entities, to provide technical assistance to
foreign countries using the same document to help
them to be sure that their -- the level of safety
of their produce is the same as ours.
That's a very quick overview of how we got
to here, of how the President put forth this
portion of the Food Safety Initiative.
Are there any questions I can answer about
this part of it anyway? Anything I've left out?
Yes?
MR. BROWL: Which of the four fruit and
vegetables --
MR. BARNES: Could you go to the microphone,
please? And also, state your name for us.
56
MR. BROWL: My name is Joseph Browl
(phonetic) I'm executive vice president of the
Florida Gift Fruit Shipper's Association.
Which of the four fruit or vegetable groups
you have considered or are still considering,
GAPS and GMPs in 1998?
MR. BARNES: None have been considered that
I'm aware of. The original proposal was that
there would be eight sometime selected, that
there would be specific good agricultural
practices or good manufacturing practices
selected for. None have been selected or even
looked at.
What was proposed was that through the
industry, through other means, eventually some
would be looked at. But as I said, that are now
being reconsidered and there are no -- at this
point in time anyway, there's a possibility that
that will not be done in the near future.
But that will happen with consultation with
everybody. Again, this is an open process.
Yes? Please go to the microphone, state
your name, please? I'm sorry, there's somebody
in the back, Stacey.
MR. ROBBINS: John Robbins, consulting
57
engineer in food sciences.
Is that a function of the criteria that's
involved, or is that a function of public comment
that there's nothing been added to that list?
MR. BARNES: The criteria were never
developed. There was never a criteria that we
had developed to that point in time.
What we had announced was that we would look
at some specific good agricultural practices for
some specific commodities. The criteria were
never developed to that point in time.
But as a result of the comments from the
first two grassroots meetings and from the
industry as a result of some other presentations,
that is being reconsidered on whether or not
there will be specific GAPS or GMPs for products.
MR. ROBBINS: Thank you.
MR. BARNES: Stacey?
DR. ZAWEL: Stacey Zawel with United Fresh
Fruit & Vegetable Association.
Richard, I missed something that you said
and wanted to get clarification on a Miami
meeting? What is that and what's it about?
MR. BARNES: Camille, help.
John, do you have that?
58
MR. VANDERVEEN: There will be -- I believe
there was another Miami meeting planned under a
different auspices and we are going to make a
presentation there.
I believe our director of the constituent
services is going to make that presentation.
There are a group of people from various
countries coming to be at that meeting anyway,
and it was an opportunity to inform them about
our program and our -- and our legislative
initiative, and that's an opportunity.
Do you have anything more to say on that,
Terry?
MR. BARNES: The meeting and, again, to
follow what John said, is a presentation; it's
not a grassroots meetings. It's a presentation.
MR. VANDERVEEN: That's right. It's just a
presentation.
MR. BARNES: Right. I'm sorry if I left you
with the impression that it's a grassroots
meeting. It is not.
MS. BREWER: It's a committee of Latin
American Action --
MR. BARNES: That's right. Latin American
Action Council.
59
MR. VANDERVEEN: This meeting was planned a
long time ago. It was put together by the
Foreign Aid Service. We were invited to
participate. It was designed to help with
providing information to countries about our
requirements in meeting the regulations that we
have for foods being sold in this country.
There were some other meetings planned in
other countries. I believe they're still going
to occur. The original focus had more to do with
pesticides and things of that sort.
MR. BARNES: Yes, ma'am?
DR. MALECKI: Hi, my name is Dr. Jean
Malecki, I'm a health officer here in Palm Beach
County.
And my question has to do with the document
itself, and I understand that it's one deeply
routed in values.
My concern, and probably this will be
discussed later -- if it wasn't going to be, I
hope it will be -- with all the guidance and
technical assistance that can be provided, my
concern is more of importation, what happens from
a regulatory standpoint if there is still
evidence of contamination?
60
MR. BARNES: Terry?
MR. TROXELL: Your question is, if we find
contamination on a product that's offered for
entry?
DR. MALECKI: If we still have continuing
human illness related --
MR. TROXELL: We would be able to take
action against those products under the Food,
Drug and Cosmetic Act.
DR. MALECKI: Well, in the past, we have
not. So I was wondering if there's going to be a
dialogue in the future in terms of relationships
contractually and so forth.
Right now, it's obvious to me that it's been
a consumer choice more than anything else. And,
again, my concern is, is that if we provide all
this guidance and technical assistance, again, my
concern is importation; what does ultimately
occur from epidemiological evidence, from public
health relationships with the folks as FDA would
have a health commission to either embargo or
stop sale.
MR. TROXELL: At this point, we would need,
under the FD&C Act, to make the link of a
poisonous or deleterious substance such as a
61
microbiological problem in the product, or that
the products were produced under unsanitary
conditions to prevent their importation.
DR. MALECKI: Thank you.
MR. BARNES: At one of the other grassroots
meetings -- and to show you that things are being
done all over the country and many of them have
been looked at in the process -- there is one
that -- one of the Cooperative Extension Services
had a brochure, Prevention of Food-Borne Illness
Begins on the Farm. And Dr. Archer, wherever you
went to -- one of the things -- I like words
anyway, and one of the first sections in here is
clean soil.
Any other questions on the first part of
this? We are waiting for coffee to be set up.
Would you like to take a short break now,
even though the coffee isn't ready, or would you
like me to go on and we'll take a break when that
gets done? We'll be flexible.
Go on? All right. We'll do that.
MS. ISAACS: Hold on, Richard.
MR. BARNES: We'll go about, maybe 15
minutes, 20 minutes?
MS. ISAACS: Okay. If you come back 15
62
minutes --
MR. BARNES: No, I thought they said go on.
MS. ISAACS: Oh, okay. All right.
MR. BARNES: So about 15 or 20 minutes and
then we'll take a break.
MS. ISAACS: Never mind.
MR. BARNES: Again, the scientists who work
on this document are in the room. When you ask
questions, if you ask me, for example, the time
and temperature requirements for composting
untreated manure in a 30 degrees centigrade
environment that's very damp, you'll see this
glazed look come across my face, and I'll start
pointing to someone.
And, also, I'm not going to go into
specifics of this whole document. We want you to
take some time to look at it, to develop opinions
on what it is. I'm going to highlight only
during this presentation what is in the guide to
minimize microbial food safety hazards for fresh
fruits and vegetables.
And so I'm going to talk about the document
in general. At the end, we'll do a short
question and answer period, then we will either
go to lunch, depending upon how we do on time.
63
Probably we'll go to lunch a little bit early and
then come back and then do the other
presentations.
The reason for the document in the beginning
of it talks about the reasons for this guide; the
recent outbreaks have raised concerns about the
safety of foods, including fresh fruits and
vegetables that are not processed to eliminate
pathogens.
And that's part of the problem. The problem
is that we do not have a way to eliminate
pathogens from some fresh fruits and vegetables.
You know the names of the microorganisms,
cyclospora, E. coli 0157:H7, Salmonella,
cryptosporidium. There are many organisms that
have been involved in outbreaks in recent years
involving fresh fruits and vegetables that are
difficult to remove. I mean, we don't have fried
lettuce sandwiches; we don't cook lettuce to 155
degrees for 15 seconds like we do a hamburger.
And so we have to be involved in the entire
process from farm to table in ensuring that we do
not -- we reduce or eliminate pathogens wherever
possible in that process.
They're not subject to many of the steps
64
that normally occur in food processing that would
eliminate or reduce microbial load that most
processed foods receive, or they aren't cooked.
Therefore, we have to find other ways to reduce
the microbial contamination, especially for raw
produce products.
And, again, at the same time, we have to do
that and what we're telling people eat more of
them; it's important to your health.
Potential vehicles for pathogenic
contamination, and which this document is divided
in, are into four areas; water, manure/municipal
sewage slush, water field facility sanitation
hygiene, and under transportation there is one
other area which is called the trace-back; where
we're now calling it positive lot identification
instead of trace- backs.
Again, as you've heard everybody say, it is
intended as guidance only; it's intended as
self-assessment. It's not a check list; it will
not contain everything that you need to know. We
will not have every bit of information that's
there. But it's to get you to think, to look at,
and evaluate your growing practices, your on-site
processing facilities, to look at what could be
65
done to minimize the food safety risks.
It encourages you to take a proactive role
in the food safety chain. It will be the first
step in the food safety chain. It has the best
advice of FDA and USDA in consultation with all
of you. The reason for the grassroots meetings
with scientists, Cooperative Extension, the
universities -- and other universities, with
anybody who is willing to provide input into that
process.
The document focuses on common elements in
growing, production, and distribution, and where
they will reduce the risk of microbial
contamination.
However, it does not contain all of the
scientific knowledge that we have or that we are
aware of, or that we know about to get everything
to answer all the questions. There are many gaps
in the science, treating manure, for example.
There has been a lot of research and work done
with municipal sewage sludges, but not as much
done with manure.
And so there's a lot of gaps in the science.
And part of this initiative is to improve the
science, to develop research, to help provide you
66
with better information for your farming
practices.
Where there's uncertainty, the guidance will
be qualified using terms like "minimize" or
"avoid" or "where feasible". And those are words
that are used in guidance. Again, somebody said
the difference between guidance and regulations;
regulations usually don't use those words, they
usually use "shall" or "may" or "do".
In this case we're saying, you want to look
at, minimize, or avoid where feasible. And
that's important because there are some times
that you cannot do that, you cannot avoid certain
things. You cannot avoid the birds flying over.
I don't know how to do that. If you invent
something, please let me know, I'll invest in it.
It is intended to provide practical advice
appropriately qualified. And appropriately
qualified means as a result of this process, of
going through the whole process of ensuring that
everybody has input.
In some areas, the guidance may properly be
more specific such as when practices are related
to federal, state, or local laws. As Martha
Roberts talked about earlier, in Florida the
67
water usage is fairly tightly controlled.
Alternate water sources may not be available to
you, so you're stuck or restricted in what you
can do based upon federal, state, or local laws.
In many cases, a packing house may come
under the Code of Federal Regulations and the
good manufacturing practices, Section 110,
because they are considered a food processing
establishment, where some are not. And that has
a lot to do with where they're located, the type
of process they're in, and so on and so forth.
And it depends, in the Code of Federal
Regulations on how they fit into that process.
Many times packing houses in the field, open
sheds where packing is done, it's gone directly
from there to the retail segment and through the
distribution chain and through the retail
segment, are not covered under that good
manufacturing practices.
Common vectors for pathogens of all fresh
produce, such as water and manure. There are
certain things that are common to growing no
matter what. And there are vectors that we know
are there. Water -- and I'm going to talk about
it in a few minutes -- is a very, common vector
68
for many, many pathogenic organisms.
On the other hand, there's also a big
difference in the size of the farms, the
regionality of farming practices, types of farms,
climate, soil differences, fertilizer sources,
employee availability, et cetera, et cetera, et
cetera.
The document will try and take into account
in being general and broad-scoped to account for
all of those things. But, again, there are some
sections that you may find in this area that do
not apply, where in other areas they do.
One of the things that I was thinking about
this morning, in the section that talks about
making sure that you restrict livestock from the
fields. And at this time of year in Oklahoma and
Texas and that part of the country, they are
grazing their cattle on the wheat fields, eating
the green tops off of them. And that's a common
practice. That's a common practice in that part
of the country, although it's not a fresh fruit
and produce, that's a common practice of letting
the cattle into the fields for the winter wheat.
Then there are cultural practices that vary
widely between different types of produce and
69
different varieties of specific types of produce.
A strawberry is not a strawberry is not a
strawberry, or a rose is a rose is a rose. How
you grow a strawberry here in Florida may be
different from the way it's grown in another part
of the country.
Martha Roberts said this morning that, for
example, many of you have already gone to drip
irrigation. Well, that's not true in other parts
of the country where they're unable to do that
for many different reasons. And so there's
different ways of doing things, even within the
same product, based upon different sections of
the country.
We want to be able to tailor it as much as
possible, but allow enough flexibility in the
document to ensure that the differences that
occur across this country can be taken into
account.
And the last question there -- I stepped
ahead too much -- is the question of why we're
here. How can we best provide practical concrete
advice to growers that will move us toward safer
produce without being unnecessarily costly to the
growers and the industry?
70
Now, that's what the guidance document is
intended to be. And how can we do that? How can
we best provide that guidance that will assist
you in ensuring the quality of the products.
Okay?
Water. Now, before we get to the actual
section, there's a couple other sections in the
document you need to be aware of.
Definitions. It talks about several
definitions. There may be some need to add some
more in there, or you can be a judge of that kind
of thing that might need to be defined a little
bit better for certain people or certain entities
in that document.
The first section is on water. And I
think -- how are we doing on the coffee? Can
you --
MS. BREWER: Ten more minutes.
MR. BARNES: Ten more minutes. Okay. Keep
talking.
Source and quality of water are extremely
important. One, because water is an inherent
source of contamination itself. Because it picks
up -- when I went to college, I learned that
water is called the universal solvent; you give
71
it enough time, it will dissolve anything, and it
will carry it with it as it goes through the
process.
And so it can pick up and become a source of
contamination itself. And you can't say because
it comes out of the water tap that it's safe
water.
If you remember the cryptosporidium outbreak
in Michigan, that's it. You've always thought,
well, if you turn the tap on, the water comes
out, it must be safe. Well, it isn't always that
way. We have to be constantly vigilant about the
water supplies that we're using to ensure that
they maintain and they stay safe. It's a very
good vehicle for spreading pathogens in the
field, during harvest, or in the packing house.
And the water you start out with may not be
contaminated, but it can become contaminated
through the process; either in the process of
washing, moving fruits or vegetables through a
flume, using water as a transportation vehicle,
cleaning the food, so on and so forth.
These are some of the organisms that can be
carried through water and have been associated
with outbreaks that are associated with different
72
types of fruits and vegetables and water
products, as well.
Because of water's potential as a source of
pathogenic microorganisms, growers should
carefully analyze their practices involving
water.
Use a lot of ground water. I just put a new
well pump in my well, and I wound up having to
chlorinate the daylights out of it to clean the
well back up again, to get the E. Coli out of my
well as a result of putting a new pump and
fooling around with it, touching it, and doing
everything else. That water was safe before, and
now it's safe again. But in between times, I had
to test it and to treat it, to make sure that it
stayed safe.
So you have to be able to look at your
practices and what you've done, what's going on,
what's happening around you involving the water
products and the water that you're using. You
want to try to seek to limit the possibility for
water-borne contamination. And that gets more
and more difficult as it goes through the
process.
Recognize the potential for water source to
73
contain pathogens. If you're using a surface
water source, is there runoff from someplace
else, are you downstream from a sewage plant, has
there been a lot of rain that has allowed runoff
from a livestock operation upstream from you. Is
there a dairy operation upstream from you where
there is a creek or a tributary that runs through
the field where the cows are pastured.
So you've got to look at what happens to the
water, and then also that it has sufficient
quality for its intended use. Using a surface
water to do the initial dirt wash off a product
that is going to then be further washed down the
road in the packing shed with a cleaner water
supply, that's the kind of process that you want
to look at. So what is its intended use. You
need to tailor it to the needs of the operation.
Now, in the document, for example, it talks
about -- I can't say it -- counter-current flow.
In other words, you want to start where the
product is supposed to be the cleanest with your
cleanest water, and if you're going to reuse that
water, like Dr. Roberts talked about this
morning, is that the water goes back towards the
beginning process so that you don't -- that you
74
use your cleanest water at the point where you
want the product to be the cleanest, and if
you're reusing that water, that it then goes --
it's reused back at a different portion, not at
the final rinse stage, for example, is one of the
ways you can do it.
And, again, the guidance does not preempt
any applicable federal, state, or local
regulations or laws or practices. You've got to
combine all of that together. Dr. Roberts said
this morning, there are plenty of regulations,
and that's true, there are. And sometimes the
regulations do what we want them to do, and
sometimes they don't.
One of the things I do other than this kind
of stuff, is I do a lot with teams and with
change. And one of the -- I believe Steven Cubby
(phonetic) said, you give a man a fish, you feed
him for a day; you teach a man to fish, you feed
him for a lifetimes.
Sometimes in the regulation business, we're
doing the former, and what we really need to do
is the latter. And sometimes this type of
document, guidance, that has the input of
everybody, does the latter.
75
Growers should consider -- don't fail me
now. So, again, do an assessment; identify and
review the source of water used on your farm. If
it's in Florida, then you're controlled by the
Department of Environmental Quality using ground
water, you still need to look at what has
happened to that ground water, what have you done
to it.
As the degree of water to produce contact
increases, so does the need for good quality
water. Again, the higher up the chain that you
get closer and closer to the consumer, the higher
the quality of water needs to be. And the review
can include determining whether the source of
water is from a well, open canal, so on and so
forth. In that process, you're going to look at
the water and what's happening to it as it gets
closer to that end product.
Now, this one; controls may include delaying
water use till the water quality improves.
That's not very practical. We realize that. But
what we want you to do is to be aware of that, be
aware of what's happening to your water so that
you can change, if necessary, do something
different.
76
Now, that may not be practical, as
Dr. Roberts said this morning. You're pretty
well controlled in the State of Florida in how
your water usage is done, but you need to look at
that process. If something does go wrong, what
are your alternatives, what kind of things can
you change in your particular operation.
Irrigation water. Again, many factors
influence the choice of an irrigation system.
Water availability and state, for example, is
what I just talked about earlier.
Cultural requirements for different types of
crops. An orchid needs a different water supply
than a strawberry or raspberries do. So in the
way that it's supplied to. Depending upon the
crop, you need to look at considering the water
delivery system that minimizes the direct water
to produce contact for certain produce, or that
that contact is far enough away from the
harvesting of the product that the likelihood of
pathogenic contamination is decreased.
Water used for crop protection sprays also
needs to be considered. Although you may say,
well, it doesn't make any difference, I'm just
mixing a pesticide with this, it's been found
77
that many pesticides mixed with the water do not
necessarily kill microorganisms that are in that
water; they're not designed to do that, so they
may survive. So the contamination could be still
there. And so the water that's used to mix crop
protection sprays also needs to be considered in
the process.
Let me catch up to my notes.
Mixing crop protection sprays. Growers need
to be sure that the water is of adequate quality
for this purpose.
Good agricultural practices to protect the
integrity of the water source. For example, if
you're using your ground water to mix a herbicide
or a pesticide, you want to be sure that, not
only is that good quality for the stuff -- the
pesticide or herbicide spray that you're going to
use to spray on the crops, but you also want to
be sure that your pesticide doesn't contaminate
your water source. There are many, many
instances around the world where someone has been
mixing pesticides or herbicides and accidentally
wound up putting it back into their water source
into the well or even into the municipal water
supply.
78
Once you get to the point where you're
using -- you're starting to wash produce, you
really need to take a better look at the water
supply to make sure it's safe and sanitary, and
that it is in a packing environment that you're
using, as you go through the process, you're
using cleaner water.
Even with sanitizers, the water might
eliminate the pathogens on the surface of the
produce, but it may not. And in some cases, the
pathogens are internalized, the wash water is not
going to do it.
When I flew in yesterday, after we came
under the clouds, I looked down, I could see a
lot of swimming pools. And I know a lot of you
know about swimming pools; this is very similar
to it; a good analogy. You put two kids in the
swimming pool and the chlorine level stays pretty
high; you put 40 kids in the swimming pool, what
happens to your chlorine level. It disappears.
The same thing is occurring when you're
washing fruits and vegetables; as you continue,
and you've lowered microbial load and it
increases in the water, even with chlorine in it,
it uses it up, and if you're not careful, if
79
you're not monitoring it, if you're not replacing
it, like an automatic system in a swimming pool
will do, the ability to kill pathogens or to
reduce them in the water goes away and becomes
virtually nothing.
There's one of the things in there that
already was commented on, on tomatoes, one of the
guidances in there was talking about washing
tomatoes with water that's ten degrees warmer
than the tomato to stop internalization of the
thing. So the growers -- many of you said, but
you don't understand, we're trying to cool the
produce and get the field heat out of it at the
same time.
And this is one of those things where we
come to you and say, here's a scientist saying,
this is a good way to keep the pathogens out of
the thing using scientific principle, and here's
a grower saying, but I've got to do something
else. Somewhere we've got to find a way that
those two come together, and that's part of,
again, why we're here.
If pathogens are not removed or inactivated,
they can spread so a significant portion of the
produce becomes contaminated. And that's, you
80
know, the old adage, the one bad apple, the
barrel of apples; same thing.
If you had one load coming out of the field
that was very highly contaminated for some
reason, and you start mixing it together in a
wash tank and washing it together, now all of
them could become contaminated if you're not
careful of what's happened with that water.
Chlorine, as Dr. Archer said, is one of the
most commonly used ones. There are some others
being used that are used in other environments,
like processing or food service environment, but
they have not been used for this type of
operation.
And again, once you get into using these
kind of things, you want to be sure that you
understand their usage, how they should be used,
and how to monitor their use during the time that
you're using it as a disinfectant.
Cooling operations. Water and ice used in
cooling should be considered a potential source
of contamination. Several food-borne illness
outbreaks have occurred as a result of ice; ice
made from an improper source or ice becoming
contaminated. It is just like a water.
81
One of the things that I deal a lot in the
retail environment, earlier this week, I said I
was working on the retail portion of the Food
Safety Initiative; we talked about many of the
same kind of things that we'll talk about later
in hygiene. You know, when people who take your
glass in a retail environment and stick it
through the ice, what have they done? Have they
contaminated the ice? Very possibly yes.
Okay. So you've got to look at that because
of outbreaks of the organisms shown here.
Growers need to be made aware of the water
source used to make ice needs to -- used for
cooling operations has to be in good sanitary
condition. But, again, it's becoming in contact
with the produce and, therefore, should not carry
pathogens to the produce, but you should do it.
Okay?
MS. BREWER: Richard? We're ready. We can
take a break now.
MR. BARNES: Okay. That's a good break.
We'll just break right here for 15 minutes.
We'll be back at 11:00 o'clock.
(Thereupon, a short recess was taken.)
MR. BARNES: We'll try and get through this
82
section of it here in about 20 minutes, do a
short question and answer, and then break for
lunch a little bit early, take an hour for lunch
and get back and then finish up this afternoon.
I'm going to try and speak a little bit
slower so that I don't wear out our
transcriptionist before lunch.
And a couple things from earlier that people
brought up. One is that, when I was talking
about water and wash water and talking about the
supply of the water, municipal supplies, potable
water supply, I did not mean to imply that, as a
grower, if you're using municipal water, you
should go test it; that should be done for you by
the entity, the municipality, the authority
providing the water to you, and they should have
the records.
So I didn't mean for -- when I was talking
about potable water, that you should be testing
water all over the place. Just be aware of your
source of water and where it comes from.
We talked about water and ice and cooling
and, finally -- and this is the very end of it --
is that, again, it's just that we want you to be
aware of the fact that water is a vehicle for
83
spreading localized contamination; that water can
carry pathogenic organisms with it, and that it
can be spread from one group of products to
another, or spread through a group of products;
that when you're using water in washing
operations, that you're aware of the potential
contamination of that water as it's being used,
and that you monitor its use throughout the
process.
Manure and sewage sludges. As I said
earlier this morning, health officials and
scientists agree that animal manure and human
fecal matter are a significant source of human
pathogens, and that untreated use of these -- use
of untreated products such as these on a product
that is not going to be further -- where the
pathogens are not going to be further reduced is
a significant risk.
The use of manure or municipal sewage sludge
in the production of produce must be closely
managed to limit potential for pathogen
contamination of produce.
Now, we know that -- and I'll talk about it
in a minute -- that there are not a lot of use of
municipal sewage sludge so much in the farming
84
community, but that it has been used. And where
I come from and was working in Oklahoma, every
spring, one of the places we went to get the best
tomato plants was at the city municipal sewage
sludge plant, because they were grown in the
drying beds and they had beautiful tomato plants
that got about that high that you could take home
and plant and grow nice tomatoes.
So it is being used, and there is more
research has been done on municipal sewage sludge
than on a lot of manure products. So there is
some evidence of its use. They know that this is
a good soil conditioner and that properly treated
sewage sludge that has pathogens reduced and does
not have heavy metals in it -- which is one of
the other things that they definitely look at --
municipal sewage sludges is a good soil
conditioner and fertilizer.
You've got to be alert to the presence of
human or animal fecal matter that may be
introduced into the produce growing and handling
environment. The use of manures, whether it's
chicken or other type of animal manure, is used
in the environments. And, again, it talks about
in the document, site packing, for example, and
85
so on. You've got to be aware of that process.
Properly treated manure or municipal sewage
sludge is a safe and effective fertilizer. But
untreated or improperly treated manure could
contain pathogens that eventually would get into
the produce and contaminate the produce.
And, for example, with some produce, leafy
produces like lettuces or whatever, if it was
contaminated, it may be very difficult, then, to
wash that product or to eliminate the pathogenic
organism from it before it goes on through the
food safety chain.
Although municipal sewage sludge is not
widely used on fields growing fresh produce,
there is a lot of information about its use and
where it has been used, and it does, again, serve
as a source -- untreated sludge serves as a
source of contamination for produce.
Again, the sources of fecal contamination,
untreated or improperly treated manure, nearby
composting or treatment operations, nearby
livestock or poultry operations, municipal
wastewater storage or disposal areas, you know,
if you have a produce field very close to a
municipal sewage plant and something happens
86
because of a rain or whatever and they have to
bypass, even though that's their -- with all the
requirements they have, if that happens, if they
bypass and it gets into your field, you need to
be aware, if that happened, the possibility of
contamination of produce.
And then, finally, the last one, high
concentrations of wildlife in growing areas. We
were talking during the break about some of the
things Dr. Archer talked about, covering ponds.
And, again, those -- that's not a thing, but
covering tanks might be a better analogy.
We would not ask -- and I was telling them
in Maryland, the deer we have, I don't care how
you build a fence, if the deer want in, they're
going to eventually get there to your garden. So
that's not -- again, it's looking at what's
around you; what types of contamination can
occur.
And Dr. Roberts was talking about, saying,
you know, putting in a produce growing area
downhill from a cattle operation is not -- would
not be considered really good practice and
should -- and would be the kind of thing we're
looking at.
87
Growers need to develop and follow good
agricultural practices for handling manure to
reduce the potential of introducing microbial
hazards of produce. And this talks about
different practices; processes such as composting
to reduce the levels of pathogens, minimizing
direct or indirect manure-to-product contact, and
assessing adjacent or nearby land to determine
the risk that it may pose as a result of water
runoff, wind blowing, and so on and so forth.
Some of the treatments to reduce pathogens
in manure; passive, nature and time. There is a
competition that occurs with the soil
microorganisms that have a tendency to overwhelm
the pathogenic organisms when it's tilled in and
it is allowed to sit for a period of time.
Active types of things, like pasteurization,
anaerobic digestion, aerobic digestion, et
cetera.
Composting divides it again, which most of
you are probably aware of, what it is and how it
helps to make the manure safer, reduce the
pathogenic or the organism level in the manure so
that it can be used as a safe amendment.
And some of the science is there, some of it
88
is not. The NCRS has some data on composting,
they have some booklets on composting we can use,
talks about some of these things that have been
done with EPA and municipal sewage sludge, two or
three days at 131 degrees, I think it is, I can't
remember what the exact temperature was. It
talks about they know that that will reduce the
thing, but some of it for manure is not known.
And, again, how you compost manure here in
Florida is going to be a lot different in
December than how you compost manure in North
Dakota, so there's a big difference in how that
works.
We don't have the data to tell you all the
time and temperature recommendations. In one of
the statements in there, it talks about -- maybe
one of my next slides -- of putting it on the
soil so many days ahead of time then leaving it,
and these are minimum amounts of time. And
there's one of them, it talks about 120 days.
And there's not really the science to support
that yet, but it's a recommendation.
Again, it will vary, depending upon whether
you're using treat or untreated manure. And,
again, here's a -- the growers may reduce the
89
risk of contamination from manure by maximizing
the time between application and harvest.
The minimums range from 40 to 60 days, but
some recommendations are 120 days or longer. And
that's a recommendation; that's not always -- and
that's part of the research process that's going
to go on under this initiative, is to look at
those kind of things to determine and to give you
better data on what kinds of things you need to
do, what kind of operations need to take place,
moving the product from outside in, et cetera, et
cetera, et cetera.
Natural fertilizer, such as composted manure
have to be produced in a manner to reduce the
likelihood of introducing microbial hazards. And
there's many questions about that. If it's been
produced in a composting facility, it gets to you
and you store it outside for a while, is it
possible for microbes to get to grow or to be
reintroduced into the composted or treated manure
for fertilizer.
So how it's handled and what happens to it
after it's been treated may have an impact, and
there's some of that information that is not
available.
90
Cross-contamination which could occur as a
result of your composting operation from stuff
being wind-blown or runoff from it going downhill
into your field where you're growing the produce.
Depends on, again, looking at the process, how
and where it's being done, is there any
likelihood of contamination occurring in that
process.
And, again, there's some -- not a clear
indication that composting or other treatments
totally eliminate the pathogens. In many cases,
you're not talking about a sterile product. It's
been reduced to a low enough level, but it's not
a sterilized product. If you were going to buy
sterilized manure, that's one thing, but if you
just composted it, it may reduce the pathogens.
But, again, in some of the organisms that
have been seen, the levels that were required to
cause food-borne illness may be very, very low.
So even though we reduce them to a very low
level, it may not be enough to eliminate the
possibility of contamination of the final
product.
So you want to consider even treated manure
under the same aspect that you might untreated
91
manure, being sure there's a long enough period
of time, even after you applied treated manure to
the product before harvesting is similarly to
what you would do for untreated manure.
Again, here it talks about cross-
contamination runoff, leaching from wind spread
from your composting operation or your manure
handling operation.
We're going to go on now and talk a little
bit about sanitation and hygiene and microbial
hazards associated with workers and people who
are working in the field.
The worker health and hygiene do play a
critical role in the controls to minimize
microbial contamination of fresh produce. The
fecal oral route is the majority of the way that
many of these pathogenic organisms affect people.
That is how it occurs; that's where the
organism is shed, from the human body, a person
who is ill, and can wind up on the hands or
something else, and wind up back in the mouth of
another person.
And so the fecal oral route is the primary
microbial concern with most of the organisms
we're talking about.
92
Good hygienic practices by workers are
essential in the control of microbial hazards.
And, again, as I had talked to you earlier or
showed you earlier the other document from farm
to table, that's part of the essential thing all
the way through to the consumers.
All of the educational campaigns, all of the
documents that you see from the entire Food
Safety Initiative reemphasize this, that good
hygienic practices from the farm all the way
through the housewife or house-husband at home
preparing the meal are necessary in order to
avoid the contamination of the food products.
People who are ill, who are working in any
part of the food safety chain, whether it's in
the field, picking produce, packing it,
distributing it, processing it, serving it,
retail to the consumer, anywhere along that line,
it's possible that it can become contaminated and
wind up causing illness.
What we would like -- and in the document it
talks about -- is to control those hazards in the
growing environment. Employees tell -- or report
to the person who's in charge about their health
as they go -- as they're working, to talk about
93
diseases that they understand